GaitNCT03886805
The Dual-task Training Under Different Priority Instructions on Gait Speed in Community-dwelling Older Adults
A study testing Dual task with variable- and fixed-priority instructions and Dual-task with variable-priority instructions in people with Gait and Postural Balance, run by University of Pernambuco at 1 site in Brazil.
Trial summary
This study analyzed the effect of different modalities of dual-task training in the improvement of gait biomechanics, postural balance, falls episodes, executive functioning, and quality of life in community-dwelling older adults. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gait, Postural Balance
- What is being tested?
- Dual task with variable- and fixed-priority instructions and Dual-task with variable-priority instructions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Apr 2019to 5 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants of both sexes
- Age between 60 and 80 years old
- Participants with a score greater or equal to 52 (up to a maximum of 56) in the Berg Balance Scale
- Participants with a score greater or equal to 24 (up to a maximum of 30) in the Mini-mental State Exam
- Participants who are able to walk uninterruptedly for a distance of 10-meter at a self-selected velocity of at least 1.0 m/s without the need from another person, cane or walker
Who cannot join
- Self-report of two or more falls in the last 12 months
- Any contraindication to balance postural training
- Any contraindication to cognitive exercise training
- With self-report of two or more falls in the last 12 months
- Who is participating or have participated, in the last 6 months, in any regular and structured physical exercise program, for 3 or more times per week
- Any chronic health condition, including cardiovascular disease, respiratory disease, stroke, active cancer, neurological or neuromuscular conditions whose exercise is contraindicated
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- Any upper or lower limb fracture in the last 6 months
- Evidence of any surgical procedures in the knees, ankles, and hips or muscle damage in the last 6 months
- Uncontrolled diabetes.
- No able to speak and understand the Portuguese language
- Refusal to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Dual-task Training With Variable- and Fixed-priority Instructions on Gait Speed in Community-dwelling Older Adults
This study analyzed the effect of different modalities of dual-task training in the improvement of gait biomechanics, postural balance, falls episodes, executive functioning, and quality of life in community-dwelling older adults. Half of the participants have undertaken a dual-task protocol training with progression from variable-priority to fixed-priority instructions, while the other half have undertaken a dual-task protocol training under variable-priority instructions.
Read the detailed description
Although dual-task training for improving postural balance is an emerging interest area, the effects of dual tasks and dual-task training on static and dynamic postural stability remain unclear. Even though variable (alternating) instructional priority dual-task training has been shown higher effect than fixed (concurrent) priority dual-task training approach to improving the balance impairments, we must consider in everyday pragmatic situations, motor, and cognitive tasks are often demanded simultaneously and this requires an individual's attention toward an external source of attention while performing a primary task. Then, our rationale for this study is older adults who underwent a training protocol composed of a dual task with variable and fixed instructional priority will achieve better improvements regarding the studied variables in comparison to the group who will be submitted a protocol composed only by dual-task with variable priority training. Therefore, this protocol for a six-month, double-blind, randomized controlled trial with six-month follow-up post-training analyzed whether examine whether a dual-task protocol training with progression from variable priority to fixed priority instructions is effective in improvement of gait biomechanics, postural balance, falls episodes, executive functioning and quality of life in community-dwelling older adults.
- Conditions
- Gait, Postural Balance
- Being tested
- Dual task with variable- and fixed-priority instructions, Dual-task with variable-priority instructions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual task with variable- and fixed-priority instructionsOther
The participants were asked to perform dual-task activities focused, interchangeable or simultaneously, on balance (motor tasks) and on cognitive tasks performance, according to the instructional priority established by the physical therapist.
Dual-task with variable-priority instructionsOther
The participants were asked to spend half the session focused on balance (motor tasks) and half the session focused on cognitive tasks performance, according to the instructional priority established by the physical therapist.
| Study group | Role | What they receive |
|---|---|---|
| Dual task with variable- and fixed-priority instructions | Experimental | Sixty-minute training sessions, 2 times a week for 24 weeks. From the 1st to 12th week the participants were trained under variable-priority instructions (half the session was focused on balance motor task and half the session focused on cognitive task performance). From the 13th to 24th week) the participants performed dual tasks under fixed-priority instructions (simultaneous focus attention on balance and cognitive tasks). The motor tasks were performed in a circuit composed of hula hoops, ropes (in a straight line and zigzag), agility ladder, traffic cones, steps, cardboard box, and other obstacles arranged on the floor (stable surface) or on mattresses (unstable surface), depending on the aiming of each training stage. The cognitive tasks will include activities such as saying fruits, animals, cities, and/or person names started with a specific letter, solving mathematical accounts, singing songs, reciting verses, working memory, among other cognitive tasks. Receives: Other: Dual task with variable- and fixed-priority instructions |
| Dual-task with variable-priority instructions | Active comparator | Sixty-minute training sessions, 2 times a week for 24 weeks (48 sessions). From the 1st to 24th week, the participants were trained under variable-priority instructions, in which they were asked to spend half the session focused on balance (motor task) and half the session focused on cognitive task performance. The motor tasks (gait and postural balance) of this protocol were performed in a circuit composed of hula hoops, ropes (in a straight line and zigzag), agility ladder, traffic cones, steps, cardboard box, and other obstacles arranged on the floor (stable surface) or on mattresses (unstable surface), depending on the aiming of each training stage. The cognitive tasks included activities such as saying fruits, animals, cities, and/or person names started with a specific letter, solving mathematical accounts, singing songs, reciting verses, rescue working memory, among other cognitive tasks. Receives: Other: Dual-task with variable-priority instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait spatiotemporal variables
These variables will be acquired by a couple of inertial sensors attached on participant's feet during walking on a 30-meter flat and level corridor under a single-task (only gait), dual-task under variable- (gait alternating with a cognitive task) and fixed-priority (gait and cognitive task performing simultaneously).
Measured: Post-randomization at week 12
Gait spatiotemporal variables
These variables will be acquired by a couple of inertial sensors attached on participant's feet during walking on a 30-meter flat and level corridor under a single-task (only gait), dual-task under variable- (gait alternating with a cognitive task) and fixed-priority (gait and cognitive task performing simultaneously).
Measured: Post-randomization at week 24
Gait spatiotemporal variables
These variables will be acquired by a couple of inertial sensors attached on participant's feet during walking on a 30-meter flat and level corridor under a single-task (only gait), dual-task under variable- (gait alternating with a cognitive task) and fixed-priority (gait and cognitive task performing simultaneously).
Measured: Post-intervention at week 12
Gait spatiotemporal variables
These variables will be acquired by a couple of inertial sensors attached on participant's feet during walking on a 30-meter flat and level corridor under a single-task (only gait), dual-task under variable- (gait alternating with a cognitive task) and fixed-priority (gait and cognitive task performing simultaneously).
Measured: Post-intervention at week 24
Secondary outcomes (104)
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during gait under single task
These biomechanical variable acquired during gait under single task will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-randomization at week 12
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during gait under single task
These biomechanical variable acquired during gait under single task will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-radomization at week 24
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during gait under single task
These biomechanical variable acquired during gait under single task will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-intervention at week 12
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during gait under single task
These biomechanical variable acquired during gait under single task will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-intervention at week 24
Tri-axial acceleration, angular velocity and displacement of the body center of mass during gait under dual-task with variable-priority instruction
These biomechanical variable acquired during gait under dual-task with variable-priority instruction will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-randomization at week 12
Tri-axial acceleration, angular velocity and displacement of the body center of mass during gait under dual-task with variable-priority instruction
These biomechanical variable acquired during gait under dual-task with variable-priority instruction will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-randomization at week 24
Tri-axial acceleration, angular velocity and displacement of the body center of mass during gait under dual-task with variable-priority instruction
These biomechanical variable acquired during gait under dual-task with variable-priority instruction will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-intervention at week 12
Tri-axial acceleration, angular velocity and displacement of the body center of mass during gait under dual-task with variable-priority instruction
These biomechanical variable acquired during gait under dual-task with variable-priority instruction will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-intervention at week 24
Tri-axial acceleration, angular velocity and displacement of the body center of mass during gait under dual-task with fixed-priority instruction
These biomechanical variable acquired during gait under dual-task with fixed-priority instruction will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-randomization at week 12
Tri-axial acceleration, angular velocity and displacement of the body center of mass during gait under dual-task with fixed-priority instruction
These biomechanical variable acquired during gait under dual-task with fixed-priority instruction will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-randomization at week 24
Tri-axial acceleration, angular velocity and displacement of the body center of mass during gait under dual-task with fixed-priority instruction
These biomechanical variable acquired during gait under dual-task with fixed-priority instruction will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-intervention at week 12
Tri-axial acceleration, angular velocity and displacement of the body center of mass during gait under dual-task with fixed-priority instruction
These biomechanical variable acquired during gait under dual-task with fixed-priority instruction will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-intervention at week 24
Tri-axial acceleration, angular velocity and displacement of the body center of mass during conventional timed up and go test.
These biomechanical variable acquired during conventional timed up and go test will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-randomization at week 12
Tri-axial acceleration, angular velocity and displacement of the body center of mass during conventional timed up and go test.
These biomechanical variable acquired during conventional timed up and go test will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-randomization at week 24
Tri-axial acceleration, angular velocity and displacement of the body center of mass during conventional timed up and go test.
These biomechanical variable acquired during conventional timed up and go test will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-intervention at week 12
Tri-axial acceleration, angular velocity and displacement of the body center of mass during conventional timed up and go test.
These biomechanical variable acquired during conventional timed up and go test will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-intervention at week 24
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during manual timed up and go test.
These biomechanical variable acquired during manual timed up and go test will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-randomization at week 12
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during manual timed up and go test.
These biomechanical variable acquired during manual timed up and go test will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-randomization at week 24
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during manual timed up and go test.
These biomechanical variable acquired during manual timed up and go test will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-intervention at week 12
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during manual timed up and go test.
These biomechanical variable acquired during manual timed up and go test will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-intervention at week 24
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during cognitive timed up and go test.
These biomechanical variable acquired during cognitive timed up and go test will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-randomization at week 12
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during cognitive timed up and go test.
These biomechanical variable acquired during cognitive timed up and go test will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-randomization at week 24
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during cognitive timed up and go test.
These biomechanical variable acquired during cognitive timed up and go test will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-intervention at week 12
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during cognitive timed up and go test.
These biomechanical variable acquired during cognitive timed up and go test will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-intervention at week 24
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Stroop test in quasi-static standing posture
These biomechanical variable acquired during performing the Stroop test in quasi-static standing posture will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-randomization at week 12
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Stroop test in quasi-static standing posture
These biomechanical variable acquired during performing the Stroop test in quasi-static standing posture will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-randomization at week 24
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Stroop test in quasi-static standing posture
These biomechanical variable acquired during performing the Stroop test in quasi-static standing posture will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-intervention at week 12
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Stroop test in quasi-static standing posture
These biomechanical variable acquired during performing the Stroop test in quasi-static standing posture will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-intervention at week 24
Tri-axial acceleration, angular velocity and displacement of the body center of mass during performing the Clinical Test of Sensory Interaction and Balance (CTSIB).
These biomechanical variable acquired during performing the Clinical Test of Sensory Interaction and Balance (CTSIB) will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-randomization at week 12
Tri-axial acceleration, angular velocity and displacement of the body center of mass during performing the Clinical Test of Sensory Interaction and Balance (CTSIB).
These biomechanical variable acquired during performing the Clinical Test of Sensory Interaction and Balance (CTSIB) will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-randomization at week 24
Tri-axial acceleration, angular velocity and displacement of the body center of mass during performing the Clinical Test of Sensory Interaction and Balance (CTSIB).
These biomechanical variable acquired during performing the Clinical Test of Sensory Interaction and Balance (CTSIB) will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-intervention at week 12
Tri-axial acceleration, angular velocity and displacement of the body center of mass during performing the Clinical Test of Sensory Interaction and Balance (CTSIB).
These biomechanical variable acquired during performing the Clinical Test of Sensory Interaction and Balance (CTSIB) will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-intervention at week 24
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Anterior Functional Reach test.
These biomechanical variable acquired during performing the Anterior Functional Reach test will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-randomization at week 12
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Anterior Functional Reach test.
These biomechanical variable acquired during performing the Anterior Functional Reach test will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-randomization at week 24
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Anterior Functional Reach test.
These biomechanical variable acquired during performing the Anterior Functional Reach test will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-intervention at week 12
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Anterior Functional Reach test.
These biomechanical variable acquired during performing the Anterior Functional Reach test will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-intervention at week 24
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Five Times Sit-to-stand test from a chair.
These biomechanical variable acquired during performing the Five Times Sit-to-stand test from a chair will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-randomization at week 12
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Five Times Sit-to-stand test from a chair.
These biomechanical variable acquired during performing the Five Times Sit-to-stand test from a chair will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-randomization at week 24
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Five Times Sit-to-stand test from a chair.
These biomechanical variable acquired during performing the Five Times Sit-to-stand test from a chair will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-intervention at week 12
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Five Times Sit-to-stand test from a chair.
These biomechanical variable acquired during performing the Five Times Sit-to-stand test from a chair will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-intervention at week 24
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Sitting-rising test from the floor.
These biomechanical variable acquired during performing the Sitting-rising test from the floor will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-randomization at week 12
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Sitting-rising test from the floor.
These biomechanical variable acquired during performing the Sitting-rising test from the floor will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-randomization at week 24
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Sitting-rising test from the floor.
These biomechanical variable acquired during performing the Sitting-rising test from the floor will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-intervention at week 12
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Sitting-rising test from the floor.
These biomechanical variable acquired during performing the Sitting-rising test from the floor will be assessed by an inertial sensor fixed on the participant's waist.
Measured: Post-intervention at week 24
Timed Up and Go conventional (TUG conventional)
Test of basic mobility skills analyzed during rising from a chair, walking, turning the obstacle, and sitting again on the chair.
Measured: Post-randomization at week 12
Timed Up and Go conventional (TUG conventional)
Test of basic mobility skills analyzed during rising from a chair, walking, turning the obstacle, and sitting again on the chair.
Measured: Post-randomization at week 24
Timed Up and Go conventional (TUG conventional)
Test of basic mobility skills analyzed during rising from a chair, walking, turning the obstacle, and sitting again on the chair.
Measured: Post-intervention at week 12
Timed Up and Go conventional (TUG conventional)
Test of basic mobility skills analyzed during rising from a chair, walking, turning the obstacle, and sitting again on the chair.
Measured: Post-intervention at week 24
Timed Up and Go manual (TUG manual)
Test of basic mobility skills analyzed during rising from a chair, walking, turning the obstacle, and sitting again on the chair, while the participant carries a dish with a cup on it.
Measured: Post-randomization at week 12
Timed Up and Go manual (TUG manual)
Test of basic mobility skills analyzed during rising from a chair, walking, turning the obstacle, and sitting again on the chair, while the participant carries a dish with a cup on it.
Measured: Post-randomization at week 24
Timed Up and Go manual (TUG manual)
Test of basic mobility skills analyzed during rising from a chair, walking, turning the obstacle, and sitting again on the chair, while the participant carries a dish with a cup on it.
Measured: Post-intervention at week 12
Timed Up and Go manual (TUG manual)
Test of basic mobility skills analyzed during rising from a chair, walking, turning the obstacle, and sitting again on the chair, while the participant carries a dish with a cup on it.
Measured: Post-intervention at week 24
Timed Up and Go cognitive (TUG cognitive)
Test the basic mobility skills analyzed during raising from a chair, walking, bypassing the obstacle, and sitting back in the chair while the participant performs a concurrent cognitive task (solving mathematical subtraction operations).
Measured: Post-randomization at week 12
Timed Up and Go cognitive (TUG cognitive)
Test the basic mobility skills analyzed during raising from a chair, walking, bypassing the obstacle, and sitting back in the chair while the participant performs a concurrent cognitive task (solving mathematical subtraction operations).
Measured: Post-randomization at week 24
Timed Up and Go cognitive (TUG cognitive)
Test the basic mobility skills analyzed during raising from a chair, walking, bypassing the obstacle, and sitting back in the chair while the participant performs a concurrent cognitive task (solving mathematical subtraction operations).
Measured: Post-intervention at week 12
Timed Up and Go cognitive (TUG cognitive)
Test the basic mobility skills analyzed during raising from a chair, walking, bypassing the obstacle, and sitting back in the chair while the participant performs a concurrent cognitive task (solving mathematical subtraction operations).
Measured: Post-intervention at week 24
Postural Balance Test (PBT)
The Postural Balance Test evaluate the static and dynamic balance, in order to verify the typology of motor regulation, i.e. the exteroceptive or visual (six items) and interoceptive or vestibular (eight items), besides the general - proprioceptive information - of the movements.
Measured: Post-randomization at week 12
Postural Balance Test (PBT)
The Postural Balance Test evaluate the static and dynamic balance, in order to verify the typology of motor regulation, i.e. the exteroceptive or visual (six items) and interoceptive or vestibular (eight items), besides the general - proprioceptive information - of the movements.
Measured: Post-randomization at week 24
Postural Balance Test (PBT)
The Postural Balance Test evaluate the static and dynamic balance, in order to verify the typology of motor regulation, i.e. the exteroceptive or visual (six items) and interoceptive or vestibular (eight items), besides the general - proprioceptive information - of the movements.
Measured: Post-intervention at week 12
Postural Balance Test (PBT)
The Postural Balance Test evaluate the static and dynamic balance, in order to verify the typology of motor regulation, i.e. the exteroceptive or visual (six items) and interoceptive or vestibular (eight items), besides the general - proprioceptive information - of the movements.
Measured: Post-intervention at week 24
Clinical Test of Sensory Interaction and Balance (CTSIB)
This test will be used to assess the sensory integration on postural balance during standing on a stable and unstable surface with eyes open and closed.
Measured: Post-randomization at week 12
Clinical Test of Sensory Interaction and Balance (CTSIB)
This test will be used to assess the sensory integration on postural balance during standing on a stable and unstable surface with eyes open and closed.
Measured: Post-randomization at week 24
Clinical Test of Sensory Interaction and Balance (CTSIB)
This test will be used to assess the sensory integration on postural balance during standing on a stable and unstable surface with eyes open and closed.
Measured: Post-intervention at week 12
Clinical Test of Sensory Interaction and Balance (CTSIB)
This test will be used to assess the sensory integration on postural balance during standing on a stable and unstable surface with eyes open and closed.
Measured: Post-intervention at week 24
Stroop test in sit posture
This test will be used to measure a participant's selective attention capacity and skills, as well as his/her processing speed ability in sit posture
Measured: Post-randomization at week 12
Stroop test in sit posture
This test will be used to measure a participant's selective attention capacity and skills, as well as his/her processing speed ability in sit posture
Measured: Post-randomization at week 24
Stroop test in sit posture
This test will be used to measure a participant's selective attention capacity and skills, as well as his/her processing speed ability in sit posture
Measured: Post-intervention at week 12
Stroop test in a quasi-static standing posture
This test will be used to measure a participant's selective attention capacity and skills, as well as his/her processing speed ability in quasi-static standing posture.
Measured: Post-intervention at week 24
Trail making test (TMT)
Trail making test will be used to assess the participants executive abilities, which requires a variety of mental abilities including letter and number recognition mental flexibility, visual scanning, and motor function of upper limbs
Measured: Post-randomization at week 12
Trail making test (TMT)
Trail making test will be used to assess the participants executive abilities, which requires a variety of mental abilities including letter and number recognition mental flexibility, visual scanning, and motor function of upper limbs
Measured: Post-randomization at week 24
Trail making test (TMT)
Trail making test will be used to assess the participants executive abilities, which requires a variety of mental abilities including letter and number recognition mental flexibility, visual scanning, and motor function of upper limbs
Measured: Post-intervention at week 12
Trail making test (TMT)
Trail making test will be used to assess the participants executive abilities, which requires a variety of mental abilities including letter and number recognition mental flexibility, visual scanning, and motor function of upper limbs
Measured: Post-intervention at week 24
Five Times Sit-to-Stand test from a chair
The functional performance of the lower limbs taken to lifting and sitting on a chair for five times. The time will be measured by a stopwatch
Measured: Post-randomization at week 12
Five Times Sit-to-Stand test from a chair
The functional performance of the lower limbs taken to lifting and sitting on a chair for five times. The time will be measured by a stopwatch
Measured: Post-randomization at week 24
Five Times Sit-to-Stand test from a chair
The functional performance of the lower limbs taken to lifting and sitting on a chair for five times. The time will be measured by a stopwatch
Measured: Post-intervention at week 12
Five Times Sit-to-Stand test from a chair
The functional performance of the lower limbs taken to lifting and sitting on a chair for five times. The time will be measured by a stopwatch
Measured: Post-intervention at week 24
Sitting-and-rising test from the floor
Sitting-and-rising test from the floor will be used to quantify how many supports (hands and/or knees or, still, hands on the knees or legs) the individual uses to sit and lift from the floor.
Measured: Post-randomization at week 12
Sitting-and-rising test from the floor
Sitting-and-rising test from the floor will be used to quantify how many supports (hands and/or knees or, still, hands on the knees or legs) the individual uses to sit and lift from the floor.
Measured: Post-randomization at week 24
Sitting-and-rising test from the floor
Sitting-and-rising test from the floor will be used to quantify how many supports (hands and/or knees or, still, hands on the knees or legs) the individual uses to sit and lift from the floor.
Measured: Post-intervention at week 12
Sitting-and-rising test from the floor
Sitting-and-rising test from the floor will be used to quantify how many supports (hands and/or knees or, still, hands on the knees or legs) the individual uses to sit and lift from the floor.
Measured: Post-intervention at week 24
Anterior functional reach test
Anterior functional reach test will be used to determine how far the participants are able to move forward within their stability limit. It is widely used to identify the risk of falling in older adults
Measured: Post-randomization at week 12
Anterior functional reach test
Anterior functional reach test will be used to determine how far the participants are able to move forward within their stability limit. It is widely used to identify the risk of falling in older adults
Measured: Post-randomization at week 24
Anterior functional reach test
Anterior functional reach test will be used to determine how far the participants are able to move forward within their stability limit. It is widely used to identify the risk of falling in older adults
Measured: Post-intervention at week 12
Anterior functional reach test
Anterior functional reach test will be used to determine how far the participants are able to move forward within their stability limit. It is widely used to identify the risk of falling in older adults
Measured: Post-intervention at week 24
Falls Efficacy Scale-International (FES-I)
The 16-item Falls Efficacy Scale-International will be used to measure the participant's fear of falling (the concerns about falling). The sum of all 16 items is considered to compute a total score. The higher the total score achieved by the participant, the higher the concerns about falling.
Measured: Post-randomization at week 12
Falls Efficacy Scale-International (FES-I)
The 16-item Falls Efficacy Scale-International will be used to measure the participant's fear of falling (the concerns about falling). The sum of all 16 items is considered to compute a total score. The higher the total score achieved by the participant, the higher the concerns about falling.
Measured: Post-randomization at week 24
Falls Efficacy Scale-International (FES-I)
The 16-item Falls Efficacy Scale-International will be used to measure the participant's fear of falling (the concerns about falling). The sum of all 16 items is considered to compute a total score. The higher the total score achieved by the participant, the higher the concerns about falling.
Measured: Post-intervention at week 12
Falls Efficacy Scale-International (FES-I)
The 16-item Falls Efficacy Scale-International will be used to measure the participant's fear of falling (the concerns about falling). The sum of all 16 items is considered to compute a total score. The higher the total score achieved by the participant, the higher the concerns about falling.
Measured: Post-intervention at week 24
Activities-specific Balance Confidence (ABC Scale)
The 16-item Activities-specific Balance Confidence Scale will be used to measure the level of balance confidence of the individual during the accomplishment in performing daily activities. The higher the total score achieved by the participant, the higher the level of balance confidence and functioning in daily activities
Measured: Post-randomization at week 12
Activities-specific Balance Confidence (ABC Scale)
The 16-item Activities-specific Balance Confidence Scale will be used to measure the level of balance confidence of the individual during the accomplishment in performing daily activities. The higher the total score achieved by the participant, the higher the level of balance confidence and functioning in daily activities
Measured: Post-randomization at week 24
Activities-specific Balance Confidence (ABC Scale)
The 16-item Activities-specific Balance Confidence Scale will be used to measure the level of balance confidence of the individual during the accomplishment in performing daily activities. The higher the total score achieved by the participant, the higher the level of balance confidence and functioning in daily activities
Measured: Post-intervention at week 12
Activities-specific Balance Confidence (ABC Scale)
The 16-item Activities-specific Balance Confidence Scale will be used to measure the level of balance confidence of the individual during the accomplishment in performing daily activities. The higher the total score achieved by the participant, the higher the level of balance confidence and functioning in daily activities
Measured: Post-intervention at week 24
Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
Medical Outcomes Study 36-Item Short-Form Health Survey will be used to evaluate the quality of life of the participants. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability
Measured: Post-randomization at week 12
Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
Medical Outcomes Study 36-Item Short-Form Health Survey will be used to evaluate the quality of life of the participants. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability
Measured: Post-randomization at week 24
Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
Medical Outcomes Study 36-Item Short-Form Health Survey will be used to evaluate the quality of life of the participants. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability
Measured: Post-intervention at week 12
Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
Medical Outcomes Study 36-Item Short-Form Health Survey will be used to evaluate the quality of life of the participants. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability
Measured: Post-intervention at week 24
Short form of the Geriatric Depression Scale (GDS-15)
This 15-item instrument will be used to evaluate the suggestive depression symptoms in the participants. Its items require a yes/no response. Answers indicating depression are in bold and italicized; score one point for each one selected. Each answer "yes" marked with X in questions 3, 4, 6, 8, 9, 10, 12, 14 and 15 or answer "no" noted in questions 1, 5, 7, 11 and 13, computes 1 point. A score of 0 to 5 is normal. A score greater than 5 indicates depression
Measured: Post-randomization at week 12
Short form of the Geriatric Depression Scale (GDS-15)
This 15-item instrument will be used to evaluate the suggestive depression symptoms in the participants. Its items require a yes/no response. Answers indicating depression are in bold and italicized; score one point for each one selected. Each answer "yes" marked with X in questions 3, 4, 6, 8, 9, 10, 12, 14 and 15 or answer "no" noted in questions 1, 5, 7, 11 and 13, computes 1 point. A score of 0 to 5 is normal. A score greater than 5 indicates depression
Measured: Post-randomization at week 24
Short form of the Geriatric Depression Scale (GDS-15)
This 15-item instrument will be used to evaluate the suggestive depression symptoms in the participants. Its items require a yes/no response. Answers indicating depression are in bold and italicized; score one point for each one selected. Each answer "yes" marked with X in questions 3, 4, 6, 8, 9, 10, 12, 14 and 15 or answer "no" noted in questions 1, 5, 7, 11 and 13, computes 1 point. A score of 0 to 5 is normal. A score greater than 5 indicates depression
Measured: Post-intervention at week 12
Short form of the Geriatric Depression Scale (GDS-15)
This 15-item instrument will be used to evaluate the suggestive depression symptoms in the participants. Its items require a yes/no response. Answers indicating depression are in bold and italicized; score one point for each one selected. Each answer "yes" marked with X in questions 3, 4, 6, 8, 9, 10, 12, 14 and 15 or answer "no" noted in questions 1, 5, 7, 11 and 13, computes 1 point. A score of 0 to 5 is normal. A score greater than 5 indicates depression
Measured: Post-intervention at week 24
The falls events
Fall events will be evaluated through a falls diary, delivered monthly by each participant. The participants should note in this diary the day and the fall causes and circumstances.
Measured: Post-randomization at week 12
The falls events
Fall events will be evaluated through a falls diary, delivered monthly by each participant. The participants should note in this diary the day and the fall causes and circumstances.
Measured: Post-randomization at week 24
The falls events
Fall events will be evaluated through a falls diary, delivered monthly by each participant. The participants should note in this diary the day and the fall causes and circumstances.
Measured: Post-intervention at week 12
The falls events
Fall events will be evaluated through a falls diary, delivered monthly by each participant. The participants should note in this diary the day and the fall causes and circumstances.
Measured: Post-intervention at week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start30 Apr 2019
- Primary completion5 Mar 2020
- Study completion5 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GaitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pernambuco
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Francis Trombini de Souza, University of Pernambuco
- Investigators
- Francis T de Souza, PhD, Principal investigator, University of Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886805
- Sponsor's protocol ID
- U1111-1229-1346
- Status last verified
- Jul 2021
- First submitted
- 12 Mar 2019
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Trombini-Souza F, de Maio Nascimento M, da Silva TFA, de Araujo RC, Perracini MR, Sacco ICN. Dual-task training with progression from variable- to fixed-priority instructions versus dual-task training with variable-priority on gait speed in community-dwelling older adults: A protocol for a randomized controlled trial : Variable- and fixed-priority dual-task for older adults. BMC Geriatr. 2020 Feb 22;20(1):76. doi: 10.1186/s12877-020-1479-2.
PubMed 32087694
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Dual-task Training With Variable- and Fixed-priority Instructions on Gait Speed in Community-dwelling Older Adults
- ClinicalTrials.gov ID
- NCT03886805
- Acronym / sponsor ID
- U1111-1229-1346
- Conditions
- Gait, Postural Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of PernambucoUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 22 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study analyzed the effect of different modalities of dual-task training in the improvement of gait biomechanics, postural balance, falls episodes, executive functioning, and quality of life in community-dwelling older adults. Half of the participants have undertaken a dual-task protocol training with progression from variable-priority to fixed-priority instructions, while the other half have undertaken a dual-task protocol training under variable-priority instructions.
Detailed description
Although dual-task training for improving postural balance is an emerging interest area, the effects of dual tasks and dual-task training on static and dynamic postural stability remain unclear. Even though variable (alternating) instructional priority dual-task training has been shown higher effect than fixed (concurrent) priority dual-task training approach to improving the balance impairments, we must consider in everyday pragmatic situations, motor, and cognitive tasks are often demanded simultaneously and this requires an individual's attention toward an external source of attention while performing a primary task. Then, our rationale for this study is older adults who underwent a training protocol composed of a dual task with variable and fixed instructional priority will achieve better improvements regarding the studied variables in comparison to the group who will be submitted a protocol composed only by dual-task with variable priority training. Therefore, this protocol for a six-month, double-blind, randomized controlled trial with six-month follow-up post-training analyzed whether examine whether a dual-task protocol training with progression from variable priority to fixed priority instructions is effective in improvement of gait biomechanics, postural balance, falls episodes, executive functioning and quality of life in community-dwelling older adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual task with variable- and fixed-priority instructions | Experimental | Other: Dual task with variable- and fixed-priority instructionsSixty-minute training sessions, 2 times a week for 24 weeks. From the 1st to 12th week the participants were trained under variable-priority instructions (half the session was focused on balance motor task and half the session focused on cognitive task performance). From the 13th to 24th week) the participants performed dual tasks under fixed-priority instructions (simultaneous focus attention on balance and cognitive tasks). The motor tasks were performed in a circuit composed of hula hoops, ropes (in a straight line and zigzag), agility ladder, traffic cones, steps, cardboard box, and other obstacles arranged on the floor (stable surface) or on mattresses (unstable surface), depending on the aiming of each training stage. The cognitive tasks will include activities such as saying fruits, animals, cities, and/or person names started with a specific letter, solving mathematical accounts, singing songs, reciting verses, working memory, among other cognitive tasks. |
| Dual-task with variable-priority instructions | Active comparator | Other: Dual-task with variable-priority instructionsSixty-minute training sessions, 2 times a week for 24 weeks (48 sessions). From the 1st to 24th week, the participants were trained under variable-priority instructions, in which they were asked to spend half the session focused on balance (motor task) and half the session focused on cognitive task performance. The motor tasks (gait and postural balance) of this protocol were performed in a circuit composed of hula hoops, ropes (in a straight line and zigzag), agility ladder, traffic cones, steps, cardboard box, and other obstacles arranged on the floor (stable surface) or on mattresses (unstable surface), depending on the aiming of each training stage. The cognitive tasks included activities such as saying fruits, animals, cities, and/or person names started with a specific letter, solving mathematical accounts, singing songs, reciting verses, rescue working memory, among other cognitive tasks. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants of both sexes
- Age between 60 and 80 years old
- Participants with a score greater or equal to 52 (up to a maximum of 56) in the Berg Balance Scale
- Participants with a score greater or equal to 24 (up to a maximum of 30) in the Mini-mental State Exam
- Participants who are able to walk uninterruptedly for a distance of 10-meter at a self-selected velocity of at least 1.0 m/s without the need from another person, cane or walker
Key exclusion criteria (11 listed)
- Self-report of two or more falls in the last 12 months
- Any contraindication to balance postural training
- Any contraindication to cognitive exercise training
- With self-report of two or more falls in the last 12 months
- Who is participating or have participated, in the last 6 months, in any regular and structured physical exercise program, for 3 or more times per week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual task with variable- and fixed-priority instructionsThe participants were asked to perform dual-task activities focused, interchangeable or simultaneously, on balance (motor tasks) and on cognitive tasks performance, according to the instructional priority established by the physical therapist. | Other | Dual task with variable- and fixed-priority instructions |
| Dual-task with variable-priority instructionsThe participants were asked to spend half the session focused on balance (motor tasks) and half the session focused on cognitive tasks performance, according to the instructional priority established by the physical therapist. | Other | Dual-task with variable-priority instructions |
Primary outcome
Gait spatiotemporal variables
Time frame: Post-randomization at week 12
These variables will be acquired by a couple of inertial sensors attached on participant's feet during walking on a 30-meter flat and level corridor under a single-task (only gait), dual-task under variable- (gait alternating with a cognitive task) and fixed-priority (gait and cognitive task performing simultaneously).
Gait spatiotemporal variables
Time frame: Post-randomization at week 24
These variables will be acquired by a couple of inertial sensors attached on participant's feet during walking on a 30-meter flat and level corridor under a single-task (only gait), dual-task under variable- (gait alternating with a cognitive task) and fixed-priority (gait and cognitive task performing simultaneously).
Gait spatiotemporal variables
Time frame: Post-intervention at week 12
These variables will be acquired by a couple of inertial sensors attached on participant's feet during walking on a 30-meter flat and level corridor under a single-task (only gait), dual-task under variable- (gait alternating with a cognitive task) and fixed-priority (gait and cognitive task performing simultaneously).
Gait spatiotemporal variables
Time frame: Post-intervention at week 24
These variables will be acquired by a couple of inertial sensors attached on participant's feet during walking on a 30-meter flat and level corridor under a single-task (only gait), dual-task under variable- (gait alternating with a cognitive task) and fixed-priority (gait and cognitive task performing simultaneously).
104 secondary outcomes
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during gait under single task
Time frame: Post-randomization at week 12
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during gait under single task
Time frame: Post-radomization at week 24
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during gait under single task
Time frame: Post-intervention at week 12
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during gait under single task
Time frame: Post-intervention at week 24
Tri-axial acceleration, angular velocity and displacement of the body center of mass during gait under dual-task with variable-priority instruction
Time frame: Post-randomization at week 12
Tri-axial acceleration, angular velocity and displacement of the body center of mass during gait under dual-task with variable-priority instruction
Time frame: Post-randomization at week 24
Tri-axial acceleration, angular velocity and displacement of the body center of mass during gait under dual-task with variable-priority instruction
Time frame: Post-intervention at week 12
Tri-axial acceleration, angular velocity and displacement of the body center of mass during gait under dual-task with variable-priority instruction
Time frame: Post-intervention at week 24
Tri-axial acceleration, angular velocity and displacement of the body center of mass during gait under dual-task with fixed-priority instruction
Time frame: Post-randomization at week 12
Tri-axial acceleration, angular velocity and displacement of the body center of mass during gait under dual-task with fixed-priority instruction
Time frame: Post-randomization at week 24
Tri-axial acceleration, angular velocity and displacement of the body center of mass during gait under dual-task with fixed-priority instruction
Time frame: Post-intervention at week 12
Tri-axial acceleration, angular velocity and displacement of the body center of mass during gait under dual-task with fixed-priority instruction
Time frame: Post-intervention at week 24
Tri-axial acceleration, angular velocity and displacement of the body center of mass during conventional timed up and go test.
Time frame: Post-randomization at week 12
Tri-axial acceleration, angular velocity and displacement of the body center of mass during conventional timed up and go test.
Time frame: Post-randomization at week 24
Tri-axial acceleration, angular velocity and displacement of the body center of mass during conventional timed up and go test.
Time frame: Post-intervention at week 12
Tri-axial acceleration, angular velocity and displacement of the body center of mass during conventional timed up and go test.
Time frame: Post-intervention at week 24
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during manual timed up and go test.
Time frame: Post-randomization at week 12
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during manual timed up and go test.
Time frame: Post-randomization at week 24
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during manual timed up and go test.
Time frame: Post-intervention at week 12
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during manual timed up and go test.
Time frame: Post-intervention at week 24
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during cognitive timed up and go test.
Time frame: Post-randomization at week 12
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during cognitive timed up and go test.
Time frame: Post-randomization at week 24
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during cognitive timed up and go test.
Time frame: Post-intervention at week 12
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during cognitive timed up and go test.
Time frame: Post-intervention at week 24
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Stroop test in quasi-static standing posture
Time frame: Post-randomization at week 12
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Stroop test in quasi-static standing posture
Time frame: Post-randomization at week 24
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Stroop test in quasi-static standing posture
Time frame: Post-intervention at week 12
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Stroop test in quasi-static standing posture
Time frame: Post-intervention at week 24
Tri-axial acceleration, angular velocity and displacement of the body center of mass during performing the Clinical Test of Sensory Interaction and Balance (CTSIB).
Time frame: Post-randomization at week 12
Tri-axial acceleration, angular velocity and displacement of the body center of mass during performing the Clinical Test of Sensory Interaction and Balance (CTSIB).
Time frame: Post-randomization at week 24
Tri-axial acceleration, angular velocity and displacement of the body center of mass during performing the Clinical Test of Sensory Interaction and Balance (CTSIB).
Time frame: Post-intervention at week 12
Tri-axial acceleration, angular velocity and displacement of the body center of mass during performing the Clinical Test of Sensory Interaction and Balance (CTSIB).
Time frame: Post-intervention at week 24
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Anterior Functional Reach test.
Time frame: Post-randomization at week 12
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Anterior Functional Reach test.
Time frame: Post-randomization at week 24
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Anterior Functional Reach test.
Time frame: Post-intervention at week 12
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Anterior Functional Reach test.
Time frame: Post-intervention at week 24
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Five Times Sit-to-stand test from a chair.
Time frame: Post-randomization at week 12
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Five Times Sit-to-stand test from a chair.
Time frame: Post-randomization at week 24
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Five Times Sit-to-stand test from a chair.
Time frame: Post-intervention at week 12
Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Five Times Sit-to-stand test from a chair.
Time frame: Post-intervention at week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Derived from this study: PubMed 32087694Trombini-Souza F, de Maio Nascimento M, da Silva TFA, de Araujo RC, Perracini MR, Sacco ICN. Dual-task training with progression from variable- to fixed-priority instructions versus dual-task training with variable-priority on gait speed in community-dwelling older adults: A protocol for a randomized controlled trial : Variable- and fixed-priority dual-task for older adults. BMC Geriatr. 2020 Feb 22;20(1):76. doi: 10.1186/s12877-020-1479-2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis T de Souza, PhD principal investigator
University of Pernambuco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual task with variable- and fixed-priority instructions and Dual-task with variable-priority instructions in people with Gait and Postural Balance, run by University of Pernambuco at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait spatiotemporal variables (time frame: Post-randomization at week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03886805, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021; AzTrials last refreshed its copy on 27 Oct 2026.